Medical Device 510 K

510(k) Clearances | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device …

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

Content of a 510(k) | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

510 (k) Statement or Summary Truthful and Accuracy Statement Proposed Labeling Specifications Substantial Equivalence Comparison Performance Additional …

510(k) Submission Process | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

Starting October 1, 2023, all 510 (k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for …

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Medical Devices Databases A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially …

510(k) Submission Programs | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-programs

Traditional 510 (k) The Traditional 510 (k) may be used for any original 510 (k) or for a change to a previously cleared device under 510 (k). Subject to the FDA's acceptance...

510(k) Frequently Asked Questions | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-frequently-asked-questions

No, the manufacture should submit the 510 (k), if required for the device. As required under 21 CFR 801.1 (c), where a device is not manufactured by the person whose name …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=DXT&KNumber=&Applicant=ACIST%20MEDICAL%20SYSTEMS&DeviceName=&Type=&ClinicalTrials=&DecisionDateTo=02%2F18%2F2023&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=dd_asc

Medical Devices; Databases - 1 to 10 of 10 Results ProductCode: DXT Applicant: ACIST MEDICAL SYSTEMS ... 510(K) Number. Decision Date. acist angiographic injection …